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Ellume.Lab Flu A+B Test and iTreat Flu A+B Flu Test Performance Versus Viral Culture and Reverse Transcriptase Polymerase Chain Reaction.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03248960
Recruitment Status : Completed
First Posted : August 15, 2017
Last Update Posted : February 1, 2018
Sponsor:
Information provided by (Responsible Party):
Ellume Pty Ltd

Brief Summary:

The primary purpose of this study is to validate the sensitivity and specificity of the iTreat Flu A+B Test and the ellume.lab Flu A+B Test in detecting influenza A and influenza B as compared to viral culture.

The secondary aims are to:

Validate the sensitivity and specificity of the iTreat Flu A+B Test and the ellume.lab Flu A+B Test in detecting influenza A and influenza B as compared to Reverse Transcriptase Polymerase Chain Reaction (RT-PCR).

Evaluate the correct interpretation of the iTreat Flu A+B Test by subjects with influenza-like symptoms.

Evaluate the subjects' satisfaction with the convenience, comfort and ease of use of the iTreat Flu A+B Test.

Evaluate the operators' satisfaction with the ease of use of the ellume.lab Flu A+B Test.


Condition or disease Intervention/treatment Phase
Influenza Diagnostic Test: iTreat Flu A+B Test Diagnostic Test: ellume.lab Flu A+B Test Diagnostic Test: Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) Diagnostic Test: Viral culture Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 381 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Prospective Multi-Centre Study of the Ellume.Lab Flu A+B Test and iTreat Flu A+B Flu Test Performance Versus Viral Culture and Reverse Transcriptase Polymerase Chain Reaction.
Actual Study Start Date : July 27, 2017
Actual Primary Completion Date : December 23, 2017
Actual Study Completion Date : December 23, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: iTreat Flu A+B Test and ellume.lab Flu A+B Test

Upper respiratory tract samples from participants will be tested with:

iTreat Flu A+B Test; ellume.lab Flu A+B Test; Reverse Transcriptase Polymerase Chain Reaction (RT-PCR); and viral culture.

Diagnostic Test: iTreat Flu A+B Test
The iTreat Flu A+B Test is a rapid in vitro diagnostic test for the detection of influenza A or influenza B in nasal swab samples. The iTreat Flu A+B Test is designed to be simple to use and generates a result within 15 minutes.

Diagnostic Test: ellume.lab Flu A+B Test
The ellume.lab Flu A+B Test is an in vitro diagnostic test intended to be used at point-of-care for the detection of influenza A or influenza B in nasal swab samples. The ellume.lab Flu A+B Test generates a result within 10 minutes.

Diagnostic Test: Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) is a molecular diagnostic technique for the detection and identification of influenza viruses, both for clinical samples and isolates. The reverse transcriptase polymerase chain reaction (RT-PCR) allows template viral RNA to be reverse transcribed producing complementary DNA (cDNA) which can then be amplified and detected.

Diagnostic Test: Viral culture
Nasopharyngeal samples will be inoculated into appropriate culture media for influenza viral culture. In this test, the virus is actually grown and further identified in the laboratory as influenza A or B.




Primary Outcome Measures :
  1. Of participants positive for influenza A by viral culture, the percentage who are positive for influenza A by iTreat Flu A+B Test. [ Time Frame: 1 day ]
    Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.

  2. Of participants positive for influenza A by viral culture, the percentage who are positive for influenza A by ellume.lab Flu A+B Test. [ Time Frame: 1 day ]
    Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.

  3. Of participants negative for influenza A by viral culture, the percentage who are negative for influenza A by iTreat Flu A+B Test. [ Time Frame: 1 day ]
    Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.

  4. Of participants negative for influenza A by viral culture, the percentage who are negative for influenza A by ellume.lab Flu A+B Test. [ Time Frame: 1 day ]
    Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.

  5. Of participants positive for influenza B by viral culture, the percentage who are positive for influenza B by iTreat Flu A+B Test. [ Time Frame: 1 day ]
    Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.

  6. Of participants positive for influenza B by viral culture, the percentage who are positive for influenza B by ellume.lab Flu A+B Test. [ Time Frame: 1 day ]
    Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.

  7. Of participants negative for influenza B by viral culture, the percentage who are negative for influenza B by iTreat Flu A+B Test. [ Time Frame: 1 day ]
    Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.

  8. Of participants negative for influenza B by viral culture, the percentage who are negative for influenza B by ellume.lab Flu A+B Test. [ Time Frame: 1 day ]
    Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.


Secondary Outcome Measures :
  1. Of participants positive for influenza A by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza A by iTreat Flu A+B Test. [ Time Frame: 1 day ]
    Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.

  2. Of participants positive for influenza A by RT-PCR, the percentage who are positive for influenza A by ellume.lab Flu A+B Test. [ Time Frame: 1 day ]
    Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.

  3. Of participants negative for influenza A by RT-PCR, the percentage who are negative for influenza A by iTreat Flu A+B Test. [ Time Frame: 1 day ]
    Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.

  4. Of participants negative for influenza A by RT-PCR, the percentage who are negative for influenza A by ellume.lab Flu A+B Test. [ Time Frame: 1 day ]
    Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.

  5. Of participants positive for influenza B by RT-PCR, the percentage who are positive for influenza B by iTreat Flu A+B Test. [ Time Frame: 1 day ]
    Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.

  6. Of participants positive for influenza B by RT-PCR, the percentage who are positive for influenza B by ellume.lab Flu A+B Test. [ Time Frame: 1 day ]
    Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.

  7. Of participants negative for influenza B by RT-PCR, the percentage who are negative for influenza B by iTreat Flu A+B Test. [ Time Frame: 1 day ]
    Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.

  8. Of participants negative for influenza B by RT-PCR, the percentage who are negative for influenza B by ellume.lab Flu A+B Test. [ Time Frame: 1 day ]
    Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.

  9. Percent of participants who correctly interpret result of iTreat Flu A+B Test. [ Time Frame: 1 day ]
    Agreement between trained staff and participants. Report as a percentage of participants with 95% confidence limits

  10. Scores from questionnaire to assess ease of use, comfort and convenience of iTreat Flu A+B Test. [ Time Frame: 1 day ]
    The ease of use questionnaire will provide total number of responses to each question and the percentage of participants selecting each response (on a 5 point Likert scale).

  11. Scores from questionnaire to assess ease of use and convenience of ellume.lab Flu A+B Test. [ Time Frame: 1 day ]
    The ease of use questionnaire will provide total number of responses to each question and the percentage of participants selecting each response (on a 5 point Likert scale).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female participants aged ≥ 18 years: iTreat Flu A+B Test and ellume.lab Flu A+B Test OR aged ≥ 1 and <18 years: ellume.lab Flu A+B Test only; and
  • Fever ≥ 37.8°C (100°F) at presentation or history or parent/guardian-reported history of fever ≥ 37.8°C (100°F) or feeling feverish within 24 hours of presentation; and
  • Rhonorrhea or blocked nose; and
  • Participant (or parent/legal guardian) capable and willing to give informed consent/assent; and
  • Participant (or parent/legal guardian) able to read and write in English.

Exclusion Criteria:

  • Participants aged <1 year.
  • Participants who have undergone treatment with Tamiflu (oseltamivir), Relenza (zanamivir) or Symmetral (amantadine) within the previous 7 days.
  • Participants who have been vaccinated by means of an influenza nasal spray/mist vaccine within the previous 7 days.
  • Participants who have had a nose bleed within the past 30 days.
  • Participants who have had recent craniofacial injury or surgery, including surgery to correct deviation of the nasal septum, within the previous 6 months.
  • Participants currently enrolled in another clinical trial or have used any investigational device within 30 days preceding informed consent.
  • Participants 18 years of age or older unable to understand English and consent to participation.
  • Parent/legal guardian of Paticipants <18 years of age unable to understand English and consent to participation of child.
  • Participants who have had prior exposure to iTreat Flu A+B Test.
  • participants who have been previously enrolled in the iE-FLU-AUS-1701 study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03248960


Locations
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Australia, Australian Capital Territory
Ochre Health Medical Centre Casey
Casey, Australian Capital Territory, Australia, 2913
Australia, New South Wales
Paratus Clinical Blacktown Trial Clinic
Blacktown, New South Wales, Australia, 2148
Paratus Clinical Kanwal Trial Clinic
Kanwal, New South Wales, Australia, 2559
Australia, Queensland
Coastal Family Health
Buddina, Queensland, Australia, 4575
Morayfield Family Doctors
Morayfield, Queensland, Australia, 4506
USC Health Clinics
Sippy Downs, Queensland, Australia, 4556
Griffith University Clinical Trial Unit
Southport, Queensland, Australia, 4125
Australia, Victoria
Emeritus Research
Malvern East, Victoria, Australia, 3145
Sponsors and Collaborators
Ellume Pty Ltd
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Responsible Party: Ellume Pty Ltd
ClinicalTrials.gov Identifier: NCT03248960    
Other Study ID Numbers: iE-FLU-AUS-1701
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No